NCT04937036

Impact of Bruxism Related Arousals on Cardiovascular Risk in Co-morbid Insomnia and Sleep Apnea

Completed Last updated 28 March 2025

What this trial tests

trial testing Polysomnography in Sleep Apnea in 119 participants. Completed in 30 March 2024.

Timeline

1 June 2021

Primary endpoint
30 January 2024

30 March 2024

Quick facts

Lead sponsor	Wroclaw Medical University
Status	Completed
Study type	OBSERVATIONAL
Enrollment	119
Start date	1 June 2021
Primary completion	30 January 2024
Estimated completion	30 March 2024
Sites	1 location across Poland

Drugs / interventions tested

• Polysomnography

Conditions studied

• Sleep Apnea — all drugs for Sleep Apnea →
• Sleep Bruxism — all drugs for Sleep Bruxism →
• Sleep Disorder — all drugs for Sleep Disorder →
• Insomnia — all drugs for Insomnia →

Sponsor

Wroclaw Medical University

Who can join

Adults 18 to 75, any sex, with Sleep Apnea or Sleep Bruxism. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Sleep disordered breathing is a common and serious health problem. According to epidemiological data, it may affect about 20% of adult population. The majority is not aware of the disease. The most common sleep disorder is obstructive sleep apnea (OSA). The essence of OSA are the episodes of airway obstruction repeated many times during sleep, as a result of which the level of partial oxygen in the blood decreases. Apnea episodes end up waking from sleep, causing sleep fragmentation, deep sleep and REM deficiency. Frequent complications of OSA are hypertension, stroke, cardiac arrhythmia, coronary artery disease and pulmonary hypertension.

Comorbid Insomnia and Sleep Apnea (COMISA) is a highly prevalent and debilitating disorder that causes additional disturbances in sleep, daytime functioning, and quality of life for patients, and is a significant diagnostic and therapeutic problem for clinicians. Although the presence of COMISA was first noticed by Christian Guilleminault and his colleagues in 1973, it received very little research attention for almost three decades. There is still lack ofclinical trials concerning this topic.

An additional problem in apnea patients is the increased incidence of bruxism. Bruxism is associated with increased masticatory muscle activity during sleep, which may be phased or tonic. It is estimated that the incidence of bruxism in the adult population is 13%. The most common symptoms of bruxism include: pathological wear and tooth sensitivity, damage to the periodontium and oral mucosa, muscle pain in the stomatognathic system, headaches and damage to prosthetic restorations. However, the symptoms of bruxism can go unnoticed for a long time, leaving patients often unaware of the problem.

The aim of this project is:

1. to determine the prevalence of sleep bruxism in COMISA, OSA and insomnia,
2. to examine of arousals (type, frequency) in COMISA, OSA and insomnia,
3. to investigate the relationship between arousals and blood pressure values and variability, arrhythmias, sinus rhythm variability, vascular endothelial dysfunction, cardiovascular risk in COMISA, OSA and insomnia.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Sleep Bruxism and Sleep Structure in Comorbid Insomnia and Obstructive Sleep Apnea (COMISA) Syndrome: A Polysomnographic Study.
   Blaszczyk B, Meira E Cruz M, Waliszewska-Prosol M, Wieckiewicz M, et al · · 2024 · cited 8× · PMID 38892864 · DOI 10.3390/jcm13113154
2. Arginase and ceruloplasmin activity in the serum of patients with polysomnography-detected sleep bruxism.
   Martynowicz H, Michałek M, Waliszewska-Prosół M, Macek P, et al · · 2025 · PMID 40990027 · DOI 10.3389/fneur.2025.1577869